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Lean production is not a new concept in the manufacturing industry. Today, it is applied throughout our everyday life; we just often don’t recognize it. When done right, lean doesn’t just change the way you manufacture; it is a philosophy that changes the way you thinkabout manufacturing. And it doesn’t only apply to the manufacturing floor... Lean can be applied anywhere in a company where productivity could benefit from the elimination of operational inefficiencies. In an article posted on Med Device Online, KMC Systems' Mike Kallelis, head of business development for the medical engineering and contract manufacturing firm, weighs in on how making Lean part of the company culture at KMC Systems benefits the company, the customer, the end user and, ultimately, patient care.

"Finding a better—and cheaper—way to do business without risking quality is becoming more and more important in today’s medical device industry. This is due to the cost and pricing pressures manufacturers are feeling from the regulators down to the customer," Kallelis states, "Our industry has seen significant consolidation, reduction of the reimbursement rates for clinical testing, introduction of new molecular diagnostic tests, and the need for field diagnostics in the third world leading to a surge in point-of-care devices. The implementation of automation, improved assays, and higher throughput instrument platforms are also cost drivers."

Citing the impact of tax laws and other market influencing factors, Kallelis states, "Implemented correctly and not just as a one-time, quick-fix exercise, Lean manufacturing is... a solution that offers new answers to old problems and can be transferable to not only the bottom line of your company but also to the overall health of your business."

With regard to adopting a company-wide Lean culture, Kallelis says, "getting your facility Lean starts with a new mind-set in both management and the production staff. And unlike Six Sigma, Lean is not about statistical analysis, so there is no need to start seeking out your engineers and mathematicians. Lean manufacturing is simply looking at a problem from a different perspective and applying cost-effective solutions to drive a productivity gain. It begins with a Lean leader in the company taking the initiative to train staff on the principles and processes of Lean and continues with the process of value stream mapping." In the article, he goes on to describe how a management team can lead the Lean effort and foster a Lean culture that is embedded into the thoughts, actions and processes of a company.

When addressing the cost savings benefits of Lean, Kallelis says, "In the case of manufacturing, where productivity is often defined as the number of units you produce per hour, per day, increasing productivity means making more product at a lower overall cost. And because you can do so using the same amount of labor and likely less materials, you can lower your overall raw material cost and your cost of goods sold." He also describes how to determine the level of Lean when touring facilities and interviewing potential medical contract manufacturing partners, stating, "the signs of a Lean facility can be seen in a number of places, making the level of a medical contract manufacturing partner’s dedication easily evident. One simple way to identify Lean is to look for one of the first Lean methods an organization implements once starting Lean." Kallelis provides insight on the 5 S’s, also known as 'the five pillars of a visual workplace' as just one of several key principles and methods to recognize and evaluate a Lean environment.